FDA WARNING_LETTER - Oneness Labs - October 13, 2020

On October 6, 2020, the FDA issued a Warning Letter to Oneness Labs for marketing unapproved new drugs, "Oneness Labs Homeopathic Skin Tag & Mole Remover" and "Oneness Homeopathic Skin Tag & Mole Remover Extra Strength," on their website and Amazon.com.

These products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d), because they are not generally recognized as safe and effective. A significant public health concern arises from the products containing bloodroot (Sanguinaria canadensis) and zinc chloride, both known corrosive agents. The combination can indiscriminately damage tissue, forming eschar, a phenomenon well-documented with "black salves."

The FDA also expressed concern about OTC mole removal products, as moles should be evaluated by a healthcare practitioner to prevent delayed cancer diagnosis or progression. The product claims, such as "remove skin tags & moles," demonstrate their intended use as drugs under 21 CFR 201.128, intended to cure, mitigate, treat, or prevent disease or affect body structure/function.

Despite being labeled as homeopathic, these products are subject to the same statutory requirements as other drugs, with no exemptions from adulteration, misbranding, or approval requirements. Oneness Labs must take